Virtual Hill Days Next Week, Following House and Senate Meetings the Last Two Weeks

This week’s Analysis and Commentary is entitled “Three Things We Heard in Senate-side Hill Meetings.” 

 

Virtual Hill Days Next Week, Following House and Senate Meetings the Last Two Weeks.  Alliance members and staff will have virtual meetings with House and Senate offices on May 22 and May 23. You don’t have to come to DC to have your voice heard about the importance of FDA!

We strongly encourage Alliance members to join us for these visits. Please let Ben Dash know of your availability for May 22 or 23. 

Non-members interested in participating should contact Steven Grossman

The Alliance thanks those members who participated in our House and Senate Hill Days during May. This week, teams of Alliance members met with staff of nearly 15 members of the Senate Appropriations Committee and the Senate Health, Education, Labor and Pensions Committee.  

The Alliance’s recommendations for FDA’s FY 25 budget were presented, focusing on the need for additional resources to adequately fund FDA’s growing responsibilities.  Teams included representatives who spoke to FDA’s food, medical product, and veterinary medicine activities.

We continued to hear of strong support for FDA, but also concerns about restrictive 302(b) allocations that will make increases difficult. For more of what this week in the Senate looked like, check out this week’s Analysis and Commentary.

As was the case with our House meetings last week, the diversity of the Alliance team and the unified message about FDA’s needs were expressly recognized in several meetings. For more of what we heard in our House meetings, go to last week’s Friday Update


Interim House 302(b) Allocations Set; Markups Scheduled. House Appropriations Committee Chairman Tom Cole (R-OK) has released interim 302(b) allocations. Chairman Cole has said levels will “adhere to law set by the Fiscal Responsibility Act—with no side deals.” This means that tens of billions of dollars in adjustments made to increase nondefense spending are not included in these preliminary allocations.  

House Appropriations Committee Ranking Member Rosa DeLauro in her statement said: “This is the exact same process we saw play out last year. ...  I call on Republicans to rethink the funding levels they released. Increase nondefense and defense funding levels by at least one percent as agreed to almost a year ago today.”

Under these interim allocations, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill will have a discretionary allocation of $25.873 billion.  According to the House Appropriations Committee, the FY 24 enacted bill had a total discretionary allocation of $26.228 billion.  That is a reduction of $355 million.

The House Subcommittee markup is scheduled for Tuesday, June 11.  The full committee markup is scheduled for Wednesday, July 10.  According to this schedule, the Agriculture/FDA bill will be the last of the twelve bills considered by the full committee.  It will follow, and be on the same day, as the Labor/HHS bill.

The Senate has not set its 302(b) allocations, nor has it announced a markup schedule.  We will provide additional information as it becomes available.

FDA Center Directors to Appear Before House Energy and Commerce Subcommittee on Health May 22. The Subcommittee on Health has scheduled a hearing titled "Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices” on May 22 at 10:30.  

Those scheduled to appear include: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research (CDER); Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research (CBER); and Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH). 

More details, including a link to a live stream, are found here.

The Alliance hosted our final budget series webinar with CDRH Director Dr. Jeff Shuren on Tuesday. On May 14, the Alliance hosted Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health (CDRH). We had in-depth conversations around FDA oversight of medical devices & medtech innovation. Find the summary here and the transcript here.

All summaries and transcripts from the Alliance Webinar Series and our other webinars can be found on our website here.

Friday Update Returns May 31. With the upcoming Congressional recess for Memorial Day, Friday Update will not be published on May 24. We will resume publication with the May 31 edition.  Even though Friday Update will not be published, Alliance staff will be available to assist members during the entire period.

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“Hurry Up and Wait” and Other Appropriations Questions

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Three Things We Heard in Senate-side Hill Meetings